Erector Spinae Versus Paravertebral in Pediatric PCNL

January 9, 2024 updated by: Hany Mostafa Esmaeil Osman, Assiut University

Ultrasound-guided Erector Spinae Plane Block Versus Ultrasound-guided Thoracic Paravertebral Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy

To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Erector spinae plane (ESP) block is an interfascial block that was first described by Forero et al. in 2016. It can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle to provide both visceral and somatic analgesia with a sensory level from T2-4 to L1-2.

. Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

  • Coagulation disorders
  • Infection at the site of injection
  • Allergy to the local anesthetics used
  • Spinal cord abnormalities or neurological deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector spinae plane block
Ultrasound-guided erector spinae plane block
Procedure: Erector spinae plane block
Ultrasound-guided erector spinae plane block
Experimental: Paravertebral
Ultrasound-guided thoracic paravertebral block
Procedure: Paravertebral block
Ultrasound-guided paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first rescue analgesia
Time Frame: The first 24 hours postoperatively
The first 24 hours postoperatively
Total consumption of nalbuphine
Time Frame: The first 24 hours postoperatively
The first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
The concentration of sevoflurane in percent
Time Frame: Through the surgery, an average of 2 hours
Through the surgery, an average of 2 hours
Systolic, diastolic, and mean blood pressure during surgery in mmHg
Time Frame: Through the surgery, an average of 2 hours
Through the surgery, an average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Actual)

September 27, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP versus Paravertebral

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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